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Bringing a new therapy to market in the European Union requires years of work across research, development, and compliance.

For medical device manufacturers, the Premarket Approval (PMA) process is the most rigorous path to market in the United States. Reserved for Class III devices that sustain life, prevent...

Last Updated: October 2026

What does a Biologics License Application (BLA) require, and how does FDA review it?

A BLA is the FDA submission required to market a biologic in the U.S. It must...

Generic drugs play a critical role in improving patient access and reducing healthcare costs. But bringing a generic to market is not a simple process. Companies must demonstrate that their...

The goal of an NDA application is to present a clear, defensible story across CMC, nonclinical, clinical, and labeling so reviewers can evaluate benefit and risk without searching for...

If you’re developing a new medical device and there’s no clear predicate on the market, you may be wondering whether the FDA’s De Novo pathway is the right route forward. The process can...

Last Updated: October 2026

What is a Clinical Trial Application (CTA), and how is it different from an IND?

Life sciences companies face some of the strictest regulatory environments in the world. From FDA and EMA oversight to global standards like ISO 13485 and GDPR, compliance requirements...

Bringing a medical device to the U.S. market is rarely simple. Teams face a maze of regulatory pathways, and for new teams working on their first development cycle, the 510(k) submission...

Last Updated: September 2026

What's the best regulatory submission tracking software for audit-ready life sciences teams? The best regulatory submission tracking software gives regulatory...

Regulatory lifecycle management (RLM) transforms compliance from a reactive burden into a strategic advantage. Companies with effective RLM processes scale faster into new markets while...